- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00514462
Carpal Tunnel Syndrome Treated With 830nm Diode Laser (CTS)
August 9, 2007 updated by: Chung Shan Medical University
Instiutional Review Board of Chung Shan Medical University Hospital
The purpose of this study is to determine that 830nm diode laser directly above the transverse carpal ligament (between the pisiform and navicular bone) on subjects' wrists, and test this therapeutic effect.
Study Overview
Detailed Description
The low level laser instrument (Painless Light PL-830, Advanced Chips & Products Crop., USA) emitted two light beams with a distance of 2.5cm between them by two laser diodes.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Taiwan
-
Chinese Taipei, Taiwan, China, 360
- Recruiting
- Chung Shan Medical University Hospital
-
Contact:
- Joe-Air Jiang, Ph.D
- Phone Number: 886-2-33665341
- Email: jajiang@ntu.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- no operation of the wrist
- first onset of CTS more than 1 year ago with repeated episodes
- never having laser treatment before.
Exclusion Criteria:
- patients with any rheumatoid arthritis
- history of metabolic disease or paralyzed limbs caused by stroke
- taking any anti-inflammatory drug
- with other treatments, such as acupuncture, physical therapy and wearing orthosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A
low level laser instrument (Painless Light PL-830, Advanced Chips & Products Crop., USA)
|
wavelength at 830nm, 9.7J/cm2 for 10 min
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
treatment effect
Time Frame: two weeks
|
two weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
EMG, Jamar dynamometer, Carpal tunnel function disability form
Time Frame: two weeks
|
two weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Chin-Ping Han, MD/PhD, Chung Shan Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Study Completion (Anticipated)
August 1, 2007
Study Registration Dates
First Submitted
August 8, 2007
First Submitted That Met QC Criteria
August 9, 2007
First Posted (Estimate)
August 10, 2007
Study Record Updates
Last Update Posted (Estimate)
August 10, 2007
Last Update Submitted That Met QC Criteria
August 9, 2007
Last Verified
August 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS07040
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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